Job description

Job Overview We are seeking a skilled Mechanical Engineer to join our manufacturing team in Mebane, North Carolina. In this role, you will be responsible for supporting and improving automated production lines, designing and redesigning mechanical systems, and driving engineering initiatives that enhance efficiency, compliance, and product quality. This is a hands-on position where you will collaborate with technicians, engineers, and cross-functional teams to troubleshoot equipment, lead process improvement projects, and contribute to new product introductions. The ideal candidate will have a strong background in mechanical engineering within a regulated manufacturing environment and a proven ability to apply statistical methods, design standards, and compliance requirements. Duties and Responsibilities • Partner with maintenance technicians to provide technical support, identify critical problem areas, and troubleshoot multiple automated production lines. • Design and redesign mechanical systems for automation, including linear motion, pneumatics, vacuum systems, vision systems, labeling equipment, pick-and-place modules, fixturing, locating, and product conveyance. • Apply transfer functions in troubleshooting and production support (Statistical Tolerance Analysis, Design for Six Sigma). • Utilize statistical methods such as process capability studies and Design of Experiments. • Lead projects focusing on design changes, process improvements, outsourcing, material cost reduction, and plant efficiency initiatives. • Participate as a core team member on new product introduction (NPI) projects, executing plans with guidance from senior engineers. • Implement engineering processes including Deviations, Engineering Change Orders, and CAPA activities with subject matter expert (SME) oversight. • Ensure compliance with engineering standards (ASME Y15.4, GD&T), ISO, FDA 21 CFR 820, and cGMP requirements. • Create models, assemblies, and drawings in SolidWorks and AutoCAD. • Produce and revise technical documentation with minimal guidance. • Support agency compliance efforts (UL, CSA, CE). • Perform obsolescence management by analyzing and replacing basic components. • Carry out all other duties and responsibilities as assigned. Knowledge and Skills • 2+ years of experience working in team-based environments. • Strong written and verbal communication skills across all levels. • Ability to represent operations and functional teams effectively. • Supports and drives change management initiatives. • Familiarity with FDA 21 CFR 820 and ISO standards (minimum 1 year in regulated environments). • Strong troubleshooting skills for manufacturing/production lines. • Project leadership and technician management experience preferred. • Functional knowledge of UL, CSA, CE compliance requirements. Candidate Requirements • Education: Bachelors Degree in Mechanical Engineering or related field. • Experience: 2-5 years in mechanical engineering, preferably within manufacturing. • Travel: Not required. • Clearance: No security clearance required. • Visa: Visa sponsorship not available. • Management Experience: Not required but preferred. Compensation & Benefits • Full benefits package provided • No relocation assistance offered • No bonus, commission, or overtime eligibility

Requirements

Must-haves

Job Overview
Duties and Responsibilities
Partner with maintenance technicians to provide technical support, identify critical problem areas, and troubleshoot multiple automated production lines.
Design and redesign mechanical systems for automation, including linear motion, pneumatics, vacuum systems, vision systems, labeling equipment, pick-and-place modules, fixturing, locating, and product conveyance.
Apply transfer functions in troubleshooting and production support (Statistical Tolerance Analysis, Design for Six Sigma).
Utilize statistical methods such as process capability studies and Design of Experiments.
Lead projects focusing on design changes, process improvements, outsourcing, material cost reduction, and plant efficiency initiatives.
Participate as a core team member on new product introduction (NPI) projects, executing plans with guidance from senior engineers.
Implement engineering processes including Deviations, Engineering Change Orders, and CAPA activities with subject matter expert (SME) oversight.
Ensure compliance with engineering standards (ASME Y15.4, GD&T), ISO, FDA 21 CFR 820, and cGMP requirements.
Create models, assemblies, and drawings in SolidWorks and AutoCAD.
Produce and revise technical documentation with minimal guidance.
Support agency compliance efforts (UL, CSA, CE).
Perform obsolescence management by analyzing and replacing basic components.
Carry out all other duties and responsibilities as assigned.
Knowledge and Skills
2+ years of experience working in team-based environments.
Strong written and verbal communication skills across all levels.
Ability to represent operations and functional teams effectively.
Supports and drives change management initiatives.
Familiarity with FDA 21 CFR 820 and ISO standards (minimum 1 year in regulated environments).
Strong troubleshooting skills for manufacturing/production lines.

Nice-to-haves

Project leadership and technician management experience preferred.
Management Experience: Not required but preferred.

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: manatal
Effort: medium

Benefits

Benefits detected in the listing.

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